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Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open anterior approach.

The Anatomic PEEK™ Cervical Fusion System with Nanotechnology consists of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 µm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Anatomic PEEK™ devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Anatomic PEEK™ devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes the 510(k) clearance for the Anatomic PEEK™ Cervical Fusion System with Nanotechnology, a medical device. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, not a study evaluating human-in-the-loop AI performance or an AI-powered diagnostic device.

Therefore, the input text does not contain the information requested regarding acceptance criteria and a study proving an AI device meets those criteria. The acceptance criteria and study details for an AI-powered device (e.g., sample size, expert ground truth, MRMC study, standalone performance) are not present in this regulatory clearance document for a physical medical implant.

The "Performance Data" section in the provided document refers to mechanical testing of the implant and MR compatibility, not a study evaluating AI diagnostic performance or human reader improvement with AI assistance.

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